FDA Clears First Over-the-Counter Continuous Glucose Monitor for Children

FDA Clears First Over-the-Counter Continuous Glucose Monitor for Children

As reported on CNET, parents and caregivers now have a new option to help monitor children’s blood sugar levels at home. The US Food and Drug Administration (FDA) has cleared Dexcom’s Stelo Glucose Biosensor System for over-the-counter (OTC) use in children as young as 2 years old who do not use insulin.

This is the first time a continuous glucose monitor (CGM) has been made available without a prescription for younger children, making it easier for families to track glucose levels without needing as much medical setup.

What This Means for Families

Stelo is designed for children with diabetes who manage their condition without insulin, as well as for those who may be at risk of developing diabetes. It can also be used by families who want to better understand how food, physical activity, and daily habits affect their child’s blood sugar.

Because it’s available over the counter, parents can access the technology more quickly—but it should still be used with guidance from a healthcare provider, especially when making any decisions about treatment or medication.

Why It Matters Now

Health experts are seeing more cases of prediabetes and Type 2 diabetes in children across the US. Having a simple, accessible way to monitor glucose levels may help families catch changes early and build healthier habits.

The FDA has highlighted that giving children access to modern health tools can support better long-term outcomes by encouraging awareness and prevention from a young age.

How the Device Works

The Stelo system includes a small sensor that is worn on the back of the upper arm. It measures glucose levels just beneath the skin and sends updates to a smartphone app about every 15 minutes. This allows parents and caregivers to see trends throughout the day instead of relying on occasional fingerstick tests.

Each sensor can be worn for up to 15 days, although children may need to replace it sooner depending on activity levels and other factors.

Safety and What to Expect

Most users tolerate the device well, but some mild side effects have been reported, such as skin irritation, discomfort, or minor infections where the sensor is placed. If any issues arise, caregivers should consult a healthcare provider.

It’s also important to note that Stelo does not replace regular medical care. Families should always talk to a doctor before making changes based on the readings.

Who Should Not Use It

Stelo isn’t suitable for everyone. It should not be used by individuals who:

  • Take insulin
  • Are on dialysis
  • Experience frequent low blood sugar episodes

Because the device does not alert users to dangerously low glucose levels, it may not provide enough protection for these groups. Additionally, anyone with a history of eating disorders should speak with a healthcare professional before using it.

The Bottom Line

The approval of Stelo for children represents an important step toward making health monitoring simpler and more accessible. For many families, it offers a practical way to stay informed about a child’s glucose levels and encourage healthier daily choices—while still keeping healthcare providers involved in the bigger picture.